Comparative evaluation of Probiotic lozenges tablets with Mouthwash containing fluoride and cetyl pyridinium chloride and chewing gum containing Xylitol on oral Streptococcus mutans coloni
Comparative evaluation of Probiotic lozenges tablets with Mouthwash containing fluoride and chewing gum containing Xylitol on oral Streptococcus mutans coloni.
Design
Clinical efficacy with three intervention groups, with parallel groups, randomized, on 72 volunteers, random permutation block method will be used for randomization.
Settings and conduct
The volunteers will be selected from the dental students of Rafsanjan University of Medical Sciences.
Sampling will be done by a non-provocation method of volunteers:
The first group will be given probiotic lozenges, the second group will be given fluoride and cetylpyridinium chloride mouthwash, and the third group will be given xylitol chewing gum.
Sampling of patients will be done before the intervention and also on days 2, 14 and 30 after the intervention and the level of Streptococcus mutans saliva will be measured in each period.
Participants/Inclusion and exclusion criteria
Exclusion criteria: suffering from any kind of systemic disease; using contraceptive pills and being pregnant; using orthodontic appliances and brackets, fixed and removable prostheses; the existence of sensitivity to probiotic products or other elements included in the study; suffering from rapid progressing caries are acute periodontal and gum diseases.
Entry criteria: proper oral hygiene; the presence of at least 6 healthy teeth in each jaw.
Intervention groups
group A receives a Lactogam lozenge daily immediately after brushing.
group B receives 15 mg of Vivaan alcohol-free general mouthwash (0.05%) twice a day.
group C consume Miradent xylitol gum four times a day.
Main outcome variables
The number of Streptococcus mutans colonies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231127060200N1
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Ali Nabavizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4991
Email address
alinabavizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-05-03, 1403/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of Probiotic lozenges tablets with Mouthwash containing fluoride and cetyl pyridinium chloride and chewing gum containing Xylitol on oral Streptococcus mutans coloni
Public title
evaluation of Probiotic lozenges, fluoride Mouthwash and Xylitol gum on Streptococcus mutans
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Proper oral hygiene (brush at least twice a day)
The presence of at least 6 healthy teeth in each jaw without caries or complex restorations and crowns
Exclusion criteria:
Suffering from any systemic disease
Use of any type of antibiotic and probiotic products during the last month
Fluoride therapy and use of fluoride or antibacterial mouthwash during the last two weeks
Using birth control pills and being pregnant
Use of orthodontic devices and brackets, fixed and mobile prosthesis
Presence of sensitivity to probiotic products or other elements in the study such as fluoride or xylitol
Suffering from rapidly progressive caries, acute periodontal and gum diseases.
smoking
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
People will be divided into 3 equal groups using random permutation block method. In this study, blocks of 9 will be used in such a way that three cards will be prepared for each group (9 cards in total) and letters A, B and C will be written on the cards, which represent the first, second and third groups. Then, when the first person enters the study, one of the 9 selection cards will be randomly selected and the person will be placed in the same group. When the second person enters, one of the remaining 8 selection cards will be selected and the person will be placed in the specified group. The process will be repeated until all 9 cards are selected (first block) and people 10 to 18 who are the second block will be placed in three groups (three people in each group) like the first block, and this process will be repeated up to 72 people. By using this method, in addition to randomly placing people in groups, the number in the three groups will be exactly equal.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2022-12-07, 1401/09/16
Ethics committee reference number
ir.rums.rec.1401.175
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The average number of Streptococcus mutans colonies
Timepoint
Sampling of patients will be done before the intervention and also on the 2nd, 14th and 30th days after the intervention.
Method of measurement
Sampling of saliva by non-stimulating method and culture
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: they will receive one lactogam lozenge daily (a product of Lactogam Company (Tehran-Iran)) immediately after brushing their teeth, and they will be asked to continue sucking the lozenge for about half an hour and avoid swallowing it quickly. They are asked not to eat, drink or have a snack for half an hour after taking the pill.
Category
Prevention
2
Description
The second intervention group: this group is asked to keep 15 mg of mouthwash (Vivaan alcohol-free General mouthwash produced by Rogin Company (Tabriz-Iran)) twice a day (after breakfast and before bed after brushing teeth) for 60 seconds. and avoid eating and drinking for at least half an hour afterwards.
Category
Prevention
3
Description
The third intervention group: This group is asked to consume Miradent xylitol gum (Hager pharma-Disburg-Germany), consume four pieces of gum daily after breakfast, lunch, snack and dinner and continue chewing it for at least 5 minutes. .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Nabavizadeh
Street address
West Shahid Mofateh Blvd., next to Aliebn Abitaleb Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
dentistry@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
رضا وزیری نژاد
Street address
Khalij-e fars Blvd., Medical School
City
Rafsanjan
Province
Kerman
Postal code
37718175911
Phone
+98 34 3131 5512
Email
rvazirinejad@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Nabavizade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Khalij-e fars Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
alinabavizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Nabavizade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khalij-e fars Blvd. Dentistry Faculty
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3424 2322
Email
alinabavizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Nabavizade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khalij-e fars Blvd., Dentistry Faculty
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3424 2322
Email
alinabavizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD